The Effect of Resistant Starch Bagels on Risk Factors of Type 2 Diabetes and Colorectal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-10-31

Brief Summary

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The purpose of this study is to determine if consumption of bagels made with resistant starch for 8 weeks can improve markers of type 2 diabetes, colon cancer and satiety in adults.

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Detailed Description

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Using a randomized, double-blind crossover study design, we will determine the effect of consuming bagels made with resistant starch daily for 8-weeks can reduce the risk of type 2 diabetes and colon cancer in an adults who are at an increased risk for type 2 diabetes. Additionally, we will compare the satiating effect of these bagels to that of a standard bagel.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Resistant Starch Bagels

Bagels made from high-resistant starch flour (provides 24g resistant starch per day)

Group Type ACTIVE_COMPARATOR

Resistant Starch

Intervention Type OTHER

In a randomized crossover fashion, participants will consume bagels that are made with either high-resistant starch or standard wheat flour, daily for a period of 8 weeks, with a 4 week washout period.

Control Bagels

Bagels made from wheat flour

Group Type PLACEBO_COMPARATOR

Resistant Starch

Intervention Type OTHER

In a randomized crossover fashion, participants will consume bagels that are made with either high-resistant starch or standard wheat flour, daily for a period of 8 weeks, with a 4 week washout period.

Interventions

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Resistant Starch

In a randomized crossover fashion, participants will consume bagels that are made with either high-resistant starch or standard wheat flour, daily for a period of 8 weeks, with a 4 week washout period.

Intervention Type OTHER

Other Intervention Names

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RS bagels

Eligibility Criteria

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Inclusion Criteria

* Males and postmenopausal females at least 40 year old
* BMI ≥25 and \<40 kg/m2
* Waist circumference ≥ 102 cm for men, ≥88cm for women
* CANRISK score ≥21 which indicates an elevated risk for type 2 diabetes

Exclusion Criteria

* Diabetes mellitus (fasting blood glucose ≥ 7.0 mmol/L)
* Restrained eating habits
* Gastrointestinal conditions (Celiac's disease, Crohn's disease, Ulcerative Colitis, Inflammatory Bowel Disease)
* Renal Conditions
* Hepatic Conditions
* Surgery or major medical event within 3 months of study start date
* Select medication use (Glycemia medications, cholesterol-lowering agents, antibiotics within 6 months of the study, other medications known to influence blood glucose insulin, cholesterol, triglycerides, incretin hormones of the digestive tract microbiome)
* Select natural health product (NHP) use (Phytosterols or phytosterol functional foods, other NHPs intended for glycemic or cholesterol control)
* Gluten allergy or intolerance
* Alcohol consumption \>15 drinks/week for men and \>10 drinks/week for women
* Significant international travel within 6 months of the starting the study, or plans to travel internationally during the study.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes